Regulations for sending Veterinary Surgical Instruments to Qatar

K

katastic

Can anyone please help or point me in the proper direction. What do I need or what are the regulations for sending surgical instruments (Class I) for veterinary use to Qatar? I have searched every possible way on google and I'm seriously exhausted. I appreciate any help if you can.

Thanks
 
Mikishots

Mikishots

Trusted Information Resource
katastic said:
Can anyone please help or point me in the proper direction. What do I need or what are the regulations for sending surgical instruments (Class I) for veterinary use to Qatar? I have searched every possible way on google and I'm seriously exhausted. I appreciate any help if you can.

Thanks
Click to expand...

Are you a manufacturer? Exporter? Just sending them to an uncle that runs a vet business over there?
 
K

katastic

we are a manufacturer/relabeler of class I surgical instruments, we received a purchase order from veterinary hospital in Qatar.
 
Mikishots

Mikishots

Trusted Information Resource
katastic said:
we are a manufacturer/relabeler of class I surgical instruments, we received a purchase order from veterinary hospital in Qatar.
Click to expand...

Under FDA requirements, pre-market approval isn't a requirement, and neither is submission of a 510(k) for devices used in veterinary medicine. If the equipment is radiological in nature, they're controlled under radiological health regulations, administered by the CDRH.

Device manufacturers who exclusively manufacture, or distribute veterinary devices are not required to register their establishments and list veterinary devices.

Now as far as the importation rules for Qatar? They may have additional rules for you to comply with. Best to ask them directly.​
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
N Regulations for Medical Device in Jamaica Other US Medical Device Regulations 0
M Classification of device according to China medical device regulations China Medical Device Regulations 4
cscalise ISO training and auditing resources for Korea MDA regulations Other Medical Device Regulations World-Wide 0
T Good Documentation Practices (GDocP) - Where are these described in the regulations? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
I MD accessory regulations EU Medical Device Regulations 2
M External audit non conformity related to applicable regulations ISO 13485:2016 - Medical Device Quality Management Systems 7
M Medical Devices Regulations and labelling requirements UAE Other Medical Device Regulations World-Wide 0
S EU Medical Device Regulations EU Medical Device Regulations 6
R UK Compliance monitoring (Auditing) of EASA/CAA Regulations 1321/2014 & 748/2012 EASA and JAA Aviation Standards and Requirements 0
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
G Regulations for research products in Europe EU Medical Device Regulations 0
J Applicable Great Britain regulations for a custom-built test rig or evaluation kit used for research purposes only. Design and Development of Products and Processes 0
E The FDA regulations (21 CFR 312.3): Is it allowable that IND sponsor involves more than one individual or organization? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
A Korean KGMP regulations on facility relocation Other Medical Device Regulations World-Wide 6
G Brazil Regulations RDC 270/2019 Other Medical Device Related Standards 0
G No new regulations in Austria medical device register after 26th Mai, 2022 EU Medical Device Regulations 0
C Is there a list of products or classifications subject to medical device regulations in El Salvador? Other Medical Device Regulations World-Wide 0
B Rework of a medical device EU regulations EU Medical Device Regulations 5
L Single-cell lithium ion battery regulations IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L Saudi regulations for Japanese non sterile scopes Japan Medical Device Regulations 0
L ANVISA’s RDC 665 replaces previous regulations including RDC 16/2013 and IN 08/2013, and comes into effect on May 2, 2022 Other Medical Device Regulations World-Wide 2
M Seeking mentor/consultant for orthopaedic soft goods regulations Job Openings, Consulting and Employment Opportunities 0
D Regulations covering Sterile product shipments ISO 13485:2016 - Medical Device Quality Management Systems 1
R Medical device regulations in African countries Other Medical Device Regulations World-Wide 1
R Regulations on Controlled Document Size (Paper Size) Document Control Systems, Procedures, Forms and Templates 4
Z Swiss Authorized representative & non-medical device regulations Other Medical Device Regulations World-Wide 0
N How to validate Regulations and Standards？ ISO 13485:2016 - Medical Device Quality Management Systems 12
G How to record Regulations and Standards as Design Inputs? Design and Development of Products and Processes 15
L EOL milestone in Medical Devices Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 1
dgrainger Informational DRAFT: The Medical Devices (Northern Ireland Protocol) Regulations 2021 UK Medical Device Regulations 1
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
J In-house (NHS) manufacture and use (by staff) of non-medical devices.. any regulations apply? UK Medical Device Regulations 6
N Competitor not complying with regulations (EU) EU Medical Device Regulations 1
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
V Regulations renewal IATF 16949 - Automotive Quality Systems Standard 1
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
M Labelling - Is there a guidance or regulations that specifically defines the 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Draft of New UK Regulations? UK Medical Device Regulations 2
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Warehousing two separate components to a finished device while meeting regulations Other US Medical Device Regulations 7
M Find updates to REACH and Rohs regulations REACH and RoHS Conversations 1
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
M Brexit The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 UK Medical Device Regulations 1
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 2
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0
T Conflict Mineral Regulations Reliability Analysis - Predictions, Testing and Standards 1

Similar threads

Top Bottom